Worries about flu shot demand -- and supply

The 82-year-old retired physician had heart disease and diabetes, but he was insistent. He did not want a flu shot last year.

"He thought there were others who were at higher risk," said Robert Hopkins, MD, associate professor of internal medicine and pediatrics at the University of Arkansas for Medical Sciences, Little Rock. "He wanted his shot to go to them, or to his children or grandchildren first."

But before the end of the season, the doctor was convinced of the importance of getting vaccinated. He did so despite the acute shortage triggered when Chiron Corp. had contamination problems that prevented it from fulfilling its share of vaccine production -- nearly half of the total expected in the United States.

Many others who normally move to the front of the line deferred their shots. But they never returned for them, even after it became clear that some areas of the country had more than enough vaccine for all who wanted or needed it. The question now: Will they ever come back?

According to several presentations at the annual National Influenza Vaccine Summit convened in May by the American Medical Association and the Centers for Disease Control and Prevention in Chicago, physicians, public health officials and influenza vaccine supply experts are concerned that, after such a significant supply disruption, those who took a pass will now be lost for good.

There are multiple reasons why. These patients might not have become ill, leading them to believe they don't really need a flu shot after all. Or last season's message that flu shots be reserved for those most in need could stick beyond its relevance.

"[People] may think 'I stepped aside and didn't die. Do I really need this vaccine?' " said Steve Cochi, MD, MPH, acting director of the CDC's National Immunization Program. "Last year was confusing."

Disruptions undermine demand

Consumer survey data collected by sanofi pasteur, an influenza vaccine manufacturer, suggests that supply interruptions, even minor ones, tend to be followed by subsequent years of decreased demand. The 2004-05 disruption was by far the most intense of recent memory.

It began as a season that was supposed to be one of plenty with vaccine for everyone but quickly turned into a famine. The message of who should get the flu vaccine changed overnight. The CDC rapidly issued new recommendations for redistributing and rationing available supplies. Eleven states even passed legislation making it illegal to immunize people who did not fall into high-risk categories.

For the most part, such actions were praised for enabling physicians and public health officials to make the best out of a bad situation. Still, now that the dust has settled, many question whether these steps, appropriate and necessary at the time, will have a long-term negative impact. They also are now strategizing about how to again ramp up interest. This challenge is compounded by the fact that future supplies are far from certain.

"We are all hopeful that there will be adequate if not ample vaccine, but we have to be prepared for all possibilities," said William Schaffner, MD, chair of the Dept. of Preventive Medicine at Vanderbilt Medical Center in Nashville. "We will have to be nimble in the event that there is an abrupt change."

The current count

At least 50 million doses are expected from sanofi pasteur, although the company could produce as much as 60 million if interest in receiving it extended beyond the usual vaccination season to include December and January. At least 3 million doses of the live attenuated nasal vaccine are expected from MedImmune.

Chiron and GlaxoSmithKline are the wild cards. Chiron could produce between 25 million and 30 million doses, but this is dependent on regulatory approval. GSK could produce as many as 35 million, but this is also not a done deal.

"Hopefully, by August, we'll be able to say that there will be 90 million doses from four manufacturers," Dr. Cochi said. "Stay tuned."

Those on the front lines, though, are creating plans based on several different scenarios. Most concede that such contingencies still might not be enough for a smooth season. Meanwhile, physicians are placing vaccine orders for the upcoming flu season and are making two requests -- one reflecting their "wish list" total and one to indicate the amount they would need for only their high-risk patients.

"What will be the crisis du jour?" said Nancy Bennett, MD, deputy director of the Monroe County (N.Y.) Dept. of Public Health. "We don't know what this year will bring, but it will undoubtedly be something we haven't thought of."

Experts say the demand issue needs to be tackled, not just for this season but also for the long term. Most see flu vaccine eventually being recommended for everyone rather than an increasingly complicated list of priority groups. In turn, this transition will lead to better preparedness for the pandemic that most experts say is long overdue.

"We have to move to universal vaccination," said Herb Young, MD, director of the scientific activities division at the American Academy of Family Physicians.